Risk Factors Update Summary
- Net losses increased from $69.1 million to $78.6 million, a significant rise of $9.5 million.
- Approval of ELEVIDYS (SRP-9001) for DMD treatment in June 2023. Interim Phase 3 results showed no significant benefit on primary endpoint but positive results on secondary endpoints.
- Accumulated deficit rose from $102 million to $181 million, a substantial increase of $79 million.
- Funding for operations extended from early 2025 to 2026, indicating an additional year of coverage.
- Addition of Pfizer Inc.'s PF-06939926 and Fordadistrogene movaparvovec in Phase 3 trial.
- Raised gross proceeds from IPO from $112.5 million to $122.9 million, a notable increase of $10.4 million.
- Cash and cash equivalents, and marketable securities decreased from $181 million to $110 million.
- Increase in full-time employees from 45 to 64 as of December 31, 2023.
- Net proceeds from ATM program and Follow-on Offering increased to $86.8 million, up from $76.9 million.
- Phase 2 clinical trials initiated for PGN-EDO51 and PGN-EDODM1, expanding clinical development efforts.
- Net proceeds of $86.8 million received from shares sold under ATM program and Follow-on Offering.
- Increase in NOL carryforwards from $254 million to $354 million as of December 31, 2023.
- Transition from first-to-invent to first-to-file patent application system outside the U.S.
- Development of gene editing treatments by Enzerna Biosciences and Design Therapeutics, Inc.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
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